Acne Vulgaris
Conditions
Keywords
Moderate Acne Vulgaris, Acne
Brief summary
The objectives of this study were to evaluate the efficacy and safety of drospirenone 3 mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with moderate acne vulgaris during 6 treatment cycles.
Interventions
The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).
DRUGPlacebo
The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female age 14-45, with 10 to 100 comedones (noninflammatory lesions), 10 to 50 inflammatory lesions (papules or pustules), and not more than 35 nodules (\<5mm) on the face).
Exclusion criteria
* Standard contraindications for use of combined oral contraceptives (class label) plus * Subjects with acne and atopia, comedonal acne or acne conglobate, sandpaper acne or acne with multiple large nodes, cysts, fistular comedones, or abscessing fistular ducts * Use of comedogenic covering cream, comedogenic sunscreens, other sex hormone preparations or any other anti-acne therapy (eg, light therapy, oleic acids, chemical pellings, mechanical extraction of comedones) * Acne therapy with sex hormone preparations given over 3 months or longer and proved to be unsuccessful * Preparations that have had an acne-inducing effect, eg, iodinated or bromated drugs, tuberculostatics, lithium, Vitamin B1, B6, B12, D3, corticoids, ACTH, anabolics, quinine, disulfiram, methoxypsoralen, phenobarbital, phenytoin, trimethadione, thyroid depressants, and certain oily cosmetics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in inflammatory lesion counts (including papules, pustules, and nodules), non-inflammatory lesion counts (including open and closed comedones), total lesion count, and the ISGA. | From baseline to Cycle 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in count of closed comedones | Visits 3-5 |
| Percentage of subjects classified as improved according to the Investigator's Overall Improvement Rating | Visits 3-5 |
| Change from baseline in count of papules | Visits 3-5 |
| Percentage of subjects classifying themselves as improved on the Subject's Overall Self-Assessment Rating | Visits 3-5 |
| Change from baseline in count of nodules | Visits 3-5 |
| Change from baseline in count of open comedones | Visits 3-5 |
| Change from baseline in count of pustules | Visits 3-5 |
Countries
United States
Outcome results
None listed